BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE ESSENTIAL, NO POWER SWITCH

    MDR report key: 12855843 · Received November 22, 2021

    Report

    Report Number
    2020362-2021-00064
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Report Date
    October 25, 2021
    Manufacturer
    POSEY PRODUCTS
    Product Code
    PJP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED SOLELY ON THE CUSTOMER¿S ALLEGATION THAT RESULTED IN A PATIENT FALL. POSEY HAS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, AS THE DEVICE WAS RETURNED TO HOSPITAL INVENTORY AND NOT SENT TO POSEY FOR EVALUATION. INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM OR SENSOR IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, OR IF THE CHAIR BELT SENSOR IS UNFASTENED. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. (B)(4). PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED PATIENT FALL VIA EMAIL. SENSOR PAD DISCARDED, RETURNING ALARM FOR EVALUATION. NO GTIN NUMBER. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753485 KEEPSAFE ESSENTIAL, NO POWER SWITCH FALL PREVENTION ALARM/SENSOR ATTACHED ONLY PJP POSEY PRODUCTS 8373NP 1713KG0598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown